Is it Beneficial to Convert to a Neutral-pH Bicarbonate/Lactate-Buffered PD Solution in Long-Term CAPD Patients? A Single-Center Prospective Study

Yoo, Tae‐Hyun; Lee, Mi Jung; Oh, Hyung Jung; Park, Sun-Hee; Han, Seung Hyeok; Kang, Shin Wook; Han, Dae Suk

doi:10.3747/pdi.2013.00284

Cited by 4 publications

(1 citation statement)

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“…This proven functionality will allow Japanese patients’ access to highly biocompatible PDFs, with lower lactate concentration and improved biocompatibility [ 16 ]. The investigative PDFs in this study use a mixture of both lactate and bicarbonate as buffer, which has been shown previously to optimize peritoneal host defense parameters in comparison to standard lactate-only PDFs [ 17 – 19 ] and to reduce inflammatory markers in peritoneal effluent [ 20 – 23 ]. The mixture also allows for a normal pH without the risk of intracellular acidosis from an overly high paCO 2 , which is unavoidable if one uses a high concentration of bicarbonate alone as a buffer [ 19 , 24 – 26 ].…”

Section: Discussionmentioning

confidence: 99%

A new peritoneal dialysis fluid for Japanese patients: a randomized non-inferiority clinical trial of safety and efficacy

Nakayama

Kawaguchi²,

Akiba

et al. 2016

Clin Exp Nephrol

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BackgroundWe report here two new peritoneal dialysis fluids (PDFs) for Japan [BLR 250, BLR 350 (Baxter Limited, Japan)]. The PDFs use two-chamber systems, and have bicarbonate and lactate buffer to a total of 35 mmol/L. In separate trials, the new PDFs were compared to two “standard” systems [PD-4, PD-2 (Baxter Limited, Japan)]. The trials aimed to demonstrate non-inferiority of peritoneal creatinine clearance (pCcr), peritoneal urea clearance (pCurea) and ultrafiltration volume (UF), and compare acid–base and electrolyte balance.MethodsWe performed randomized, multicenter, parallel group, controlled, open-label clinical trials in stable continuous ambulatory peritoneal dialysis (CAPD) patients. The primary endpoints were pCcr and UF. The secondary endpoints were serum bicarbonate and peritoneal urea clearance. The active phase was 8 weeks. These trials were performed as non-inferiority studies, with the lower limit of non-inferiority for pCcr and UF set at 3.2 L/week/1.73 m2 and 0.12 L/day, respectively.Results108 patients (28 centers) and 103 patients (29 centers) took part in the two trials. Groups were well balanced at baseline. The investigative PDFs were non-inferior to the “standard” ones in terms of primary endpoints, comparable in terms of pCurea, and superior in terms acid–base balance, especially correcting those with over-alkalinization at baseline.ConclusionsWe demonstrated fundamental functionality of two new PDFs and showed superior acid–base balance. Given the propensity of Japanese CAPD patients for alkalosis, it is important to avoid metabolic alkalosis which is associated with increased cardiovascular mortality risk and accelerated vascular calcification. The new PDFs are important progress of CAPD treatment for Japanese patients.Electronic supplementary materialThe online version of this article (doi:10.1007/s10157-016-1346-9) contains supplementary material, which is available to authorized users.

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